Study on Autologous Osteoblastic Cells Implantation to Early Stage Osteonecrosis of the Femoral Head

Brief description of study

Non-traumatic osteonecrosis is a painful disorder of the hip characterized by a necrosis of
the osteomedullary tissue, which leads to subchondral bone collapse and joint destruction.
Core decompression is currently the treatment of choice for early stage osteonecrosis of the
femoral head. This method consists in decompressing the rigid intra-osseous chamber to
promote revascularization, thus halting progression of the disease and stimulating repair.
Still this treatment remains highly controversial, since the success rates of the first
studies have not been repeated.

Three studies have indicated the potential clinical benefits of cell-based approaches for the
treatment of osteonecrosis (Hernigou 1997, Hernigou & Beaujean 2002, Gangji et al. 2004).
This is on the basis of these observations that a proprietary population of autologous
osteoblastic cells (PREOB) has been developed.

This Phase 3 study aims at demonstrating the efficacy and safety of PREOB in the treatment
of early stage osteonecrosis of the femoral head. More specifically, the purpose of the study
is to demonstrate that core decompression/PREOB implantation into the necrotic lesion is
superior to core decompression/placebo implantation in relieving hip symptoms and halting (or
reverting) radiological progression of the disease.